What side effects are associated with this type of intervention?

Common treatments for Premature Ovarian Failure (POF) include hormone replacement therapy (HRT) and ovulation induction agents. Side effects of HRT can include bloating, breast tenderness, headaches, and mood swings. Ovulation induction agents, such as clomiphene citrate and gonadotropins, may cause ovarian hyperstimulation syndrome (OHSS), multiple pregnancies, and hot flashes. For treatments involving growth factors like Platelet Rich Plasma (PRP), potential side effects could include injection site pain, infection, and local inflammation. However, the efficacy and safety of PRP for POF are still under investigation, and more research is needed to fully understand its side effects.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Premature Ovarian Failure (POF) that directly involve the use of growth factors similar to Platelet Rich Plasma (PRP). Current treatments for POF primarily focus on hormone replacement therapy (HRT) to manage symptoms and prevent long-term health issues associated with estrogen deficiency. The use of PRP in ovarian rejuvenation is still under investigation and has not yet received FDA approval.

What other types of research exist?

Promising novel alternatives to PRP for Premature Ovarian Failure patients include stem cell therapy and regenerative medicine approaches. Stem cell therapy, particularly using adipose-derived stem cells (ADSCs), is being investigated for its potential to improve ovarian function and follicular recruitment. Additionally, low-intensity shock therapy (LIST) is another emerging technology that may stimulate ovarian function through neovascularization and improved blood flow. Both therapies are still under investigation but show potential as future treatments for POF.

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Platelet Rich Plasma

PRP for Diminished Ovarian Reserve (PRP4AGE Trial)

Q: What is the mechanism of action of this treatment?

Platelet Rich Plasma (PRP) is being studied for its potential to treat Premature Ovarian Failure (POF) by activating follicular recruitment pathways through growth factors. PRP injections into the ovaries aim to stimulate the growth of dormant primordial follicles, thereby enhancing ovarian function and improving fertility outcomes. This mechanism is significant for POF patients as it offers a targeted approach to address the core issue of follicular inactivity, potentially increasing the chances of conception.

N/A

Recruiting

Research Sponsored by Center for Human Reproduction

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 54 years and under

Age 54 years and under.

Must not have

Age > 54 years

Marked thrombocytopenia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial involves injecting a special preparation of a woman's own blood into her ovaries to help improve fertility. It targets women who have not responded well to typical fertility treatments. The treatment works by using growth factors in the blood to stimulate egg growth in the ovaries.

Who is the study for?

This trial is for women under 55 with diminished ovarian reserve, evidenced by a poor response to ovulation induction and specific hormone levels (FSH > 12, AMH < 1.1). Participants should not have taken Aspirin or Motrin for a week before treatment. Women with blood diseases, autoimmune conditions like lupus, or those on certain medications are excluded.

What is being tested?

The study tests if injecting Platelet Rich Plasma (PRP) into the ovaries can stimulate follicle growth in women who've had inadequate responses to fertility treatments. Following PRP injections, routine fertility drugs will be used until hCG trigger.

What are the potential side effects?

While the side effects of PRP are not detailed here, common ones may include pain at injection site, infection risk increase due to needle use, bleeding or bruising from the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 54 years old or younger.

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I am 54 years old or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am older than 54 years.

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I have a very low platelet count.

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I am on blood thinners.

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My blood pressure and heart rate are stable.

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I currently have sepsis.

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I do not have any ongoing infections.

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I have an autoimmune disease like lupus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Emergence of new ovarian follicles with evidence of estradiol production

Secondary study objectives

Change in serum AMH

Number of participants that establish a Clinical Pregnancy

Number of participants with retrieval of oocytes in an IVF cycle

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: A-PRPExperimental Treatment1 Intervention

The cortex of each ovary will be injected with autologous platelet rich plasma.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

A-PRP

2018

N/A

~40

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Platelet Rich Plasma (PRP) is being studied for its potential to treat Premature Ovarian Failure (POF) by activating follicular recruitment pathways through growth factors. PRP injections into the ovaries aim to stimulate the growth of dormant primordial follicles, thereby enhancing ovarian function and improving fertility outcomes. This mechanism is significant for POF patients as it offers a targeted approach to address the core issue of follicular inactivity, potentially increasing the chances of conception.